新型药用辅料乙交酯丙交酯共聚物中单体残留量的测定

Determination of residual lactic and glycolic contents in the new excipient poly(lactic-co-glycolic acid)

目的：建立内标法测定乙交酯丙交酯共聚物（PLGA）中单体残留量的气相色谱检测方法。方法：采用气相色谱法进行测定：内标物为乙酸丁酯；色谱柱为DB-5柱（30m×0．53mm，5um）；进样口温度为250℃；分流比10：1；载气为氮气；柱温为135℃；检测器为火焰离子检测器（FID），检测器温度为300℃；进样量为3uL。结果：采用气相色谱法测定PLGA中乙交酯与丙交酯的含量，乙交酯与丙交酯的线性范围分别为17．67～83．30和33．33～266．70ug·mL-1，加标回收率分别为99．0％和100．6％，相对标准偏差分别为0．7％和1．0％。结论：经方法学验证，该法简便、快捷、灵敏度高、结果准确，适用于PLGA中乙交酯与丙交酯的检测。

Objective： To establish a quantitative method for determination of lactic and glycolic contents in PLGA by gas chromatography with internal standard substance. Methods： N-butyl acetate was used as an internal standard substance and a capillary gas chromatographic method was carried out. DB-5 capillary column （30 m × 0.53 mm,5 um） was used, the injection port temperature was 250 ℃ , and the split ratio was 10： 1. The carrier gas was nitrogen and the initial column temperature was 135 ℃. The temperature of FID was set at 300 ℃ , and the sample volume was set at 3 uL. Results： The concentration of glycolic and lactic was linearly within 17.67 - 83.30 and 33.33 -266.70 ug. mL-1, respectively. The recovery of glycolic and lactic was 99.0% and 100.6% , and the relative standard deviation was 0.7% and 1.0%. Conclusion： The method is simple, rapid, sensitive and accurate. It is suitable for the content determination of residual lactic and glycolic in PLGA.